Browse Device Recalls

20 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 20 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 20 FDA device recalls.

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Date	Product	Reason	Class	Firm
Dec 11, 2013	SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simvie...	In a very rare occurrence an intended movement of the SimView NT simulation system components cou...	Class II	Siemens Medical Solutions USA, Inc
Dec 5, 2013	PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. ...	Update to correct the possibility for patients or operators to have their fingers trapped or pinc...	Class II	Siemens Medical Solutions USA, Inc
Oct 23, 2013	SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: a...	A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Ac...	Class II	Siemens Medical Solutions USA, Inc
Oct 23, 2013	SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any ph...	A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Ac...	Class II	Siemens Medical Solutions USA, Inc
Jul 18, 2013	PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/...	Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT...	Class II	Siemens Medical Solutions USA, Inc
May 29, 2013	Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTI...	The information regarding the FILM Mode calibration may have been considered difficult to interpr...	Class II	Siemens Medical Solutions USA, Inc
May 29, 2013	ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended ...	The potential for a safety issue, for the image quality degradation, that is addressed by the Cus...	Class II	Siemens Medical Solutions USA, Inc
Apr 4, 2013	Software correction applies to customers who use the RT Therapist RTT4.2.108...	Software update to fix multiple safety related issues.	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2013	SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT...	Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its...	Class II	Siemens Medical Solutions USA, Inc
Jan 17, 2013	SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Pa...	Siemens became aware of a potential safety issue when using the "In-session resumption" feature o...	Class II	Siemens Medical Solutions USA, Inc
Dec 20, 2012	ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of th...	A potential safety risk with the MOSAIQ Oncology Information System that has been identified by...	Class II	Siemens Medical Solutions USA, Inc
Jun 25, 2012	ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version ...	Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interl...	Class II	Siemens Medical Solutions USA, Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.